Browse Device Recalls

35,226 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,226 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 35,226 FDA device recalls, Class II.

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DateProductReasonClassFirm
May 4, 2026 MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCO... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL,... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Numb... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Me... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, A... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Ki... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Ki... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS,... Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acqui... Class II Micromed S.p.A.
May 1, 2026 Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combinati... GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... Class II GE Medical Systems, LLC
May 1, 2026 Giraffe OmniBed, a combination of an infant incubator and an infant warmer, A... GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... Class II GE Medical Systems, LLC
May 1, 2026 Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and... GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... Class II GE Medical Systems, LLC
May 1, 2026 CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: C... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog ... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: ... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to pr... Class II Philips North America Llc
May 1, 2026 CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalo... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
May 1, 2026 Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalo... Stent delivery system may encounter complications during deployment which may result in high resi... Class II INSPIREMD Inc
Apr 30, 2026 BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL... Due to an increase rate of balloon pinhole defects. Class II MICROVENTION INC.
Apr 30, 2026 Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, ... Surgical instruments used during shoulder arthroplasty procedures does not progressively translat... Class II Medacta Usa Inc
Apr 30, 2026 Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burr... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burr... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, bu... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burr... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burr... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burr... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, bur... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, tre... Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class II SURGIFY MEDICAL OY
Apr 30, 2026 directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number... Assayed Whole blood control contains labeling with incorrect performance range. Class II Accriva Diagnostics, Inc.
Apr 30, 2026 TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT... An increase in incidence in complaints of a loose outer knife and reports of the outer knife beco... Class II D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Apr 30, 2026 Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Apr 30, 2026 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr ... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Halyard, Drape Pack. Kit Code: LMDP36-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class II AVID Medical, Inc.
Apr 30, 2026 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr ... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Numbe... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr ... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.
Apr 30, 2026 Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Numbe... Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... Class II Avanos Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.